Randomized clinical trial to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery compared to amniotic membrane graft in terms of recurrence during the first year after surgery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Recurrence rate in both techniques. Defined as the number of recurrences per technique divided by the surgeries performed with amniotic membrane implant and those using fibrin-rich growth factor graft. Recurrence is understood as the appearance of fibrovascular proliferation invading the corneal limbus and the cornea. This will be evaluated during follow-up at one month, two months, three months, six months, and one year after the intervention.
研究概览
简要总结
To evaluate the efficacy, through the recurrence rate during the first postoperative year, of fibrin membrane graft and eye drops of autologous growth factor concentrate in primary pterygium surgery, comparing it with amniotic membrane graft.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Primary pterygium, unilateral or bilateral, with fibrovascular proliferation growth.
- •Patients aged between 20 and 60 years.
- •Corneal invasion with risk of visual impairment and/or ocular discomfort due to pterygium.
排除标准
- •Previous pterygium surgery (recurrent pterygium).
- •Pseudopterygium.
- •Use of topical or systemic immunosuppressive or immunomodulatory treatment.
- •Chronic use of topical ocular treatment except for artificial tears.
- •History of eyelid or ocular surface disease.
结局指标
主要结局
Recurrence rate in both techniques. Defined as the number of recurrences per technique divided by the surgeries performed with amniotic membrane implant and those using fibrin-rich growth factor graft. Recurrence is understood as the appearance of fibrovascular proliferation invading the corneal limbus and the cornea. This will be evaluated during follow-up at one month, two months, three months, six months, and one year after the intervention.
Recurrence rate in both techniques. Defined as the number of recurrences per technique divided by the surgeries performed with amniotic membrane implant and those using fibrin-rich growth factor graft. Recurrence is understood as the appearance of fibrovascular proliferation invading the corneal limbus and the cornea. This will be evaluated during follow-up at one month, two months, three months, six months, and one year after the intervention.
次要结局
未报告次要终点
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau